Although the FDA acknowledged that “many single-ingredient oral colchicine products have been used by the medical community for decades,” because these medications had not received “mandatory modern-day FDA-approval” they rarely provided physicians and patients with the important safety data and information about drug interactions and dosing that are essential when making informed treatment decisions. Thus, the FDA action to ban their sale and distribution.

At the time of the announcement, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER), said “The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets. Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Noting that the unapproved colchicines medications had never been evaluated by the FDA and thus should not be viewed as generic drugs, which must be “approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug,” Deborah M. Autor, director of CDER’s Office of Compliance, said “It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA’s current approval standards or off the market.”

One source for FDA-approved colchicine for gout
The only company manufacturing and marketing single-ingredient colchicine medications that applied for FDA approval and submitted its product to the rigorous testing and approval process was URL Pharma, maker of Colcrys.

Whereas many of the older, now-banned unapproved formulations of colchicine were available for mere pennies per pill, URL Pharma priced Colcrys at $5 per pill. The company said the price was justified by the high cost of approval testing, colchicine research, and physician education. As noted in this article in Slate, the company also was granted three years of market exclusivity for Colcrys for the treatment of gout, as well as a seven-year exclusivity period for Familial Mediterranean Fever.

The Slate piece also said that URL Pharma and the FDA defended the process by pointing out the safety concerns surrounding the use of unapproved colchicines (the article said “FDA officials have noted that colchicine had been associated with 117 non-overdose deaths, half of them involving an interaction between colchicine and the antibiotic clarithromycin”). Now, for the first time, the medication label for colchicine includes dosing and drug-interaction information. URL Pharma also contends that its research discovered that the drug was effective at much lower dosages than it was commonly prescribed at, another safety benefit from the approval process that also resulted in reduced side effects for patients.

Not everybody was happy with this turn of events
The removal of alternative colchicine products from the market, coupled with the high price of Colcrys, prompted physicians and patients alike to raise concerns over limited access to a drug that was relied on by thousands of patients. An advocacy letter sent to members by the American College of Rheumatology said that “the unanticipated increase in cost for colchicine has been extremely disappointing to all of us and our patients.” The letter also notified members that the ACR had contacted several manufacturers of unapproved colchicine “to encourage new drug applications for FDA approval of chronic gout” in the hopes that market competition URL Pharma and Colcrys would result in lower prices.

In response to these concerns, URL Pharma recently announced an “enhanced” version of the Colcrys Co-Pay Assistance Program, an initiative “designed to help patients save money on their health insurance co-payment for Colcrys.” Under the revised program, patients with health insurance can use a coupon to obtain Colcrys for $15 per month (reduced from the previous price of $25 per month). In a “Colcrys Myths and Facts” resource on its website, the company also notes that “uninsured and Medicare Part D patients with household incomes of up to three times the federal poverty level (up to $66,000 per year for a family of four) can receive Colcrys free of charge. Uninsured and Medicare Part D patients with household incomes between three to four times the federal poverty level (up to $88,000 per year for a family of four) can receive Colcrys for $5 a month. Uninsured and Medicare Part D patients with household incomes between four to six times the federal poverty level (up to $132,000 per year for a family of four) can receive Colcrys for $25 a month.”

However, an article in Pharmacy Practice News said that some physicians are “worried that health insurance companies will limit or discontinue completely payments for Colcrys.”Current ACR president David Borenstein, MD, said that “in practice many patient assistance programs are not extended by providers to patients and often are difficult for patients to maintain over time.”

HCPLive wants to know:

Do you recommend the use of oral colchicine for your patients with gout?

Has the removal from the market of cheaper prophylactic gout alternatives been a financial burden on patients?

Do support the FDA's actions to remove unapproved drugs from the market in this manner?